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Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS) (PERCING)

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Metformin and FSHr
Ovarian drilling by FERTILOSCOPY
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, FERTILOSCOPY, Ovarian hyperstimulation, Multiple pregnancies, Patient with PCOS (Rotterdam criteria), Failure of treatment with Clomiphene Citrate, Age between 18 and 36 years old, Spermogram must be normal, Permeability of Fallopian tubes

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 36 years old
  • Female patient with PCOS (Rotterdam criteria)
  • Failure of treatment with Clomiphene Citrate
  • Informed consent
  • Female patient with medical assurance
  • Patient in failure with PCOS and Clomiphene citrate

Exclusion Criteria:

  • Female patient is over 36 years old
  • Thyroid disease (4<TSH<0.3 mUI/L)
  • Virilizing tumor
  • FERTILOSCOPY non possible (Douglas cul de sac clinically fixed)
  • Anormality of SPERMOGRAM (abnormal time of migration of survival)
  • Prolactin > 1.5 N
  • Anormality of 17-OH Progesterone (<2 ng/mL)
  • Fallopian tubes non permeable TMS< 5 Millions
  • Female patient participant or have been participated to another clinical trial during the last month before the inclusion
  • Female patient without medical assurance

Sites / Locations

  • Hopital Antoine BeclereRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up

Secondary Outcome Measures

Evaluation of tolerance
Occurrence of multiple pregnancies
Duration of the menstrual cycles and hormonal ovarian dosages
Occurrence of spontaneous miscarriages
Body Mass Index with each visit

Full Information

First Posted
September 19, 2006
Last Updated
October 3, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Hopital Antoine Beclere, Hôpital Jean Verdier, Jean Rostand Intercommoned Hospital, Centre Hospitalier Universitaire, Amiens, University Hospital, Caen, University Hospital, Clermont-Ferrand, Lille Hospital : Jeanne de Flandre Hospital, University Hospital, Strasbourg, France, CMCO SIHCUS, Schiltingheim, Study and research center of sterility (Lyon)
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1. Study Identification

Unique Protocol Identification Number
NCT00378729
Brief Title
Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
Acronym
PERCING
Official Title
PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Hopital Antoine Beclere, Hôpital Jean Verdier, Jean Rostand Intercommoned Hospital, Centre Hospitalier Universitaire, Amiens, University Hospital, Caen, University Hospital, Clermont-Ferrand, Lille Hospital : Jeanne de Flandre Hospital, University Hospital, Strasbourg, France, CMCO SIHCUS, Schiltingheim, Study and research center of sterility (Lyon)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies. The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal
Detailed Description
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies. The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY. 126 patients will be necessary in each group (with interval of equivalence : 10%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, FERTILOSCOPY, Ovarian hyperstimulation, Multiple pregnancies, Patient with PCOS (Rotterdam criteria), Failure of treatment with Clomiphene Citrate, Age between 18 and 36 years old, Spermogram must be normal, Permeability of Fallopian tubes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin and FSHr
Other Intervention Name(s)
treatment for infertility
Intervention Description
treatment for infertility
Intervention Type
Procedure
Intervention Name(s)
Ovarian drilling by FERTILOSCOPY
Other Intervention Name(s)
surgical ovarian drilling
Intervention Description
surgical ovarian drilling
Primary Outcome Measure Information:
Title
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
Time Frame
during 9 months of follow-up
Secondary Outcome Measure Information:
Title
Evaluation of tolerance
Time Frame
during the study
Title
Occurrence of multiple pregnancies
Time Frame
at the end of the study
Title
Duration of the menstrual cycles and hormonal ovarian dosages
Time Frame
during the study
Title
Occurrence of spontaneous miscarriages
Time Frame
at the end of the study
Title
Body Mass Index with each visit
Time Frame
at each visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 36 years old Female patient with PCOS (Rotterdam criteria) Failure of treatment with Clomiphene Citrate Informed consent Female patient with medical assurance Patient in failure with PCOS and Clomiphene citrate Exclusion Criteria: Female patient is over 36 years old Thyroid disease (4<TSH<0.3 mUI/L) Virilizing tumor FERTILOSCOPY non possible (Douglas cul de sac clinically fixed) Anormality of SPERMOGRAM (abnormal time of migration of survival) Prolactin > 1.5 N Anormality of 17-OH Progesterone (<2 ng/mL) Fallopian tubes non permeable TMS< 5 Millions Female patient participant or have been participated to another clinical trial during the last month before the inclusion Female patient without medical assurance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hervé FERNANDEZ, MD,PhD
Phone
+33(0)- 1 45 37 44 69
Email
herve.fernandez@abc.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé FERNANDEZ, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Antoine Beclere
City
Clamart
ZIP/Postal Code
92170
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé FERNANDES, MD,PhD
Phone
+33(0)- 1 45 37 44 69
Email
herve.fernandez@abc.aphp.fr
First Name & Middle Initial & Last Name & Degree
Hervé FERNANDEZ, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15559352
Citation
Fernandez H, Watrelot A, Alby JD, Kadoch J, Gervaise A, deTayrac R, Frydman R. Fertility after ovarian drilling by transvaginal fertiloscopy for treatment of polycystic ovary syndrome. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):374-8. doi: 10.1016/s1074-3804(05)60054-0.
Results Reference
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Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)

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